Total Knee Arthroplasty (TKA) patients may present with effusion, pain, stiffness and functional impairment. A positive metal hypersensitivity (positive LTT) may be an indication for a revision surgery with a custom-made implant devoid of any hypersensitivity-related metal or an implant with the least possible ion content of the metal hypersensitivity, if no custom-made is available. The purpose of the current study is to assess the prevalence of metal hypersensitivity in subjects requiring a primary TKA and assess their early functional outcomes.

We are recruiting 660 subjects admitted for TKA. Subjects are randomly assigned to 2 groups: oxidized zirconium implant group or cobalt-chrome implant group. Functional outcomes and quality of life (QoL) are measured pre operatively, 3, 6 and 12 months post operatively with WHOQOL-BREF (domain1-Physical Health, domain 2- Psychological, domain 3- Social relationships, domain 4-Environment), KSS, KOOS and pain Visual Analog Scale (VAS). LTT and metal ions are evaluated pre operatively and 12 months post-surgery.

One hundred-sixty patients, 98 women, were enrolled in the study. Mean age was 65.6±8.9. Mean follow up (FU) was 7.1±3.8 months. Eighty-one (50.6%) were randomised in the cobalt-chrome group. Infection rate was 1.9%, one patient required debridement. Three patients (1.9%) presented with contracture at three months FU. At 12 months, WHOQOL-BREF domain 1, 2 and 4 improved significantly (p0,05).

Overall, all 160 patients improved their functional outcomes and QoL. At 12 months, VAS scores decreased from 7±2.06 at baseline to 1.95±2.79. Furthermore, the high prevalence of positive LTT (27/65) do not seem to affect early functional outcomes and QoL on patients that may have received a potential implant with hypersensitivity (18/27).

Treatment of proximal humerus fractures (PHF) is controversial in many respects, including the choice of surgical approach for fixation when using a locking plate. The classic deltopectoral (DP) approach is believed to increase the risk of avascular necrosis while making access to the greater tuberosity more difficult. The deltoid split (DS) approach was developed to respect minimally invasive surgery principles. The purpose of the present study (NCT-00612391) was to compare outcomes of PHF treated by DP and DS approaches in terms of function (Q-DASH, Constant score), quality of life (SF12), and complications in a prospective randomized multicenter study.

From 2007 to 2016, all patients meeting the inclusion/exclusion criteria in two University Trauma Centers were invited to participate in the study. Inclusion criteria were: PHF Neer II/III, isolated injury, skeletal maturity, speaking French or English, available for follow-up (FU), and ability to fill questionnaires. Exclusion criteria: Pre-existing pathology to the limb, patient-refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), axillary nerve impairment, open fracture. After consent, patients were randomized to one of the two treatments using the dark envelope method. Pre-injury status was documented by questionnaires (SF12, Q-DASH, Constant score). Range of motion was assessed. Patients were followed at two weeks, six weeks, 3-6-12-18-24 months. Power calculation was done with primary outcome: Q-DASH.

A total of 92 patients were randomised in the study and 83 patients were followed for a minimum of 12 months. The mean age was 62 y.o. (+- 14 y.) and 77% were females. There was an equivalent number of Neer II and III, 53% and 47% respectively. Mean FU was of 26 months. Forty-four patients were randomized to the DS and 39 to the DP approach. Groups were equivalent in terms of age, gender, BMI, severity of fracture and pre-injury scores. All clinical outcome measures were in favor of the deltopectoral approach. Primary outcome measure, Q-DASH, was better statistically and clinically in the DP group (12 vs 26, p=0,003). Patients with DP had less pain and better quality of life scores than with DS (VAS 1/10 vs 2/10 p=0,019 and SF12M 56 vs 51, p=0,049, respectively). Constant-Murley score was higher in the DP group (73 vs 60, p=0,014). However, active external rotation was better with the DS approach (45° vs 35°). There were more complications in DS patients, with four screw cut-outs vs zero, four avascular necrosis vs one, and five reoperations vs two. Calcar screws were used for a majority of DP fixations (57%) vs a minority of DS (27%) (p=0,012).

The primary hypothesis on the superiority of the deltoid split incision was rebutted. Functional outcome, quality of life, pain, and risk of complication favoured the classic deltopectoral approach. Active external rotation was the only outcome better with DS. We believe that the difficulty of adding calcar screws and intramuscular dissection in the DS approach were partly responsible for this difference. The DP approach should be used during Neer II and III PHF fixation.